Pilot explores organ donation in the ED — Challenges raised

Goal is to help offset nationwide shortage of available organs

It is not current practice in most EDs, and it is not without controversy. In fact, one ethicist has called the practice "ghoulish." However, a government-funded pilot program at University of Pittsburgh Medical Center (UPMC) — Presbyterian Hospital and Allegheny General Hospital, both in Pittsburgh, is seeking to make organ donation from the ED a reality, while at the same time addressing the ethical challenges that have been raised and the logistical challenges that can lower the odds for success.

Using a $321,000 grant from the Department of Health and Human Services, the EDs at these facilities have started identifying donors among patients who doctors are unable to save and taking steps to preserve their organs so a transplant team can rush to try to retrieve them.

"Obviously transplants can be lifesaving, and with large numbers of people waiting for organs and a smaller supply of donated organs for those participating recipients, we are always looking for an opportunity to increase donation," notes Clifton Callaway, MD, PhD, associate professor of emergency medicine, University of Pittsburgh School of Medicine, vice chair of emergency medicine at UPMC, and the project leader.

In the past at UPMC Presbyterian, when organ donors died in the ED, staff notified the local organ procurement organization and expected some effort would be made to determine if the patient could make a donation, says Callaway. "It turns out, however, that since there was no mechanism in the ED to temporize and buy time, and no transplant surgeon was standing by, it was not even considered" by the organ procurement organization, he says.

In the pilot program, those issues are addressed. "What we created was a new set of logistics for activating the donation after a circulatory death emergency," says Callaway.

Now, he says, when there is an unexpected death in the ED, instead of "leisurely" filling out paperwork and the "death packet" of paperwork and then contacting the organ procurement organization, staff members have been directed to attempt to make the call immediately to see if the patient is a donor. "Our first call is to them," Callaway says. "We don't know [if the person is an organ donor] prior to death."

While donor status might be designated on a driver's license in Pennsylvania, "because that often is not found with a potential donor, that information is also recorded electronically in a registry when you get your driver's license," he says. The organ procurement organization can access that registry electronically to search for an individual. "The registry also allows persons who do not have a driver's license — e.g. blind individuals or those with a history of seizures — to designate their status," he adds.

Steps when patient is a donor

If the person is a donor, staff are paged. A separate team comes in from wherever they are: elsewhere in the hospital, on campus or off. The team includes one physician, one perfusionist, a social worker, and one procurement organization specialist, who is the donation coordinator. Callaway notes that when he is part of the team, he is not assigned regular duty in the ED.

"When I arrive, I confirm the person is in fact a potential donor, that they have in fact been declared dead, and then prepare the [femoral, arterial, and venous] lines," says Callaway.

The goal of the perfusionist is to keep the organs as cold as possible. The team attempts to cool down the recently deceased person using infusions of cold fluids to buy time and convert the warm ischemic time into cold ischemic time. "This gives enough time for the transplant surgeon to arrive and see if they can procure any organs," says Callaway.

Transplant surgeons typically like to have access to organs within five minutes of death, if possible, he says. Beyond 30 minutes or an hour, transplantation might not be possible. "If the patient can be made cold, we can open a time window so the surgeon can do the transplant an hour and one-half or two hours later, which can be physically possible," Callaway says.

Ethicists and others have raised several objections to this type of process. For example, they question whether patients who designate themselves as organ donors anticipate such a situation. Family members might wonder whether the ED staff did all they could to save their loved one, because they know that time was of the essence, they say.

Callaway says everything possible has been done to avoid potential conflicts of interest. "The ethical debate is intriguing, but I think it does not completely appreciate the type of donation we're talking about here in the ED. I feel this is the least ethically ambiguous process you could imagine," he says. "In terms of an unexpected death, that's what I, and I believe most people, think about when they signed up to be an organ donor."

What's more, he says, the patients are pronounced dead only after a maximal resuscitation effort. "They are not brain dead; this is real, total, absolute death," Callaway says. "If the program did not exist, we would walk away, with the next step being a call to the funeral home. There is nothing ambiguous about it."

Callaway emphasizes that with an entirely separate team involved with organ donation and not involved with patient care, "that's a firewall to prevent conflicts of interest."

Still, Leslie M. Whetstine, PhD, MA, a bioethicist and an assistant professor of philosophy at Walsh University in North Canton, OH, has concerns. "This doesn't really alleviate the problem of a family's discomfort at having the body of a loved one violated without consent," Whetstine says. "The situation is controlled when you have a patient, if competent, who decides they no longer want to be on life support, or their surrogate is making that decision. Death is the outcome they foresee."

In these cases or organ donation, "Someone is walking down the street one day. The next thing you know the family is told, 'There's nothing we could have done, but we've cannulated them, and we'd like to take their organs now,'" she says. "That, I think, is a little bit ghoulish."

In addition, claims Whetstine, the protocol calls for a declaration of death two minutes after the heart has stopped. "You really ought to be waiting minimum of 10 minutes," she says. "The possibility of return of spontaneous circulation has been documented in patients who have had CPR."

Callaway debates this comment because, he says, "it confuses our protocol with donation after an anticipated death. In fact, to be eligible for our protocol, a potential donor would have their heart stop unexpectedly and then have CPR conducted for a period of time determined by the emergency medical team with the intention of restoring pulses."

This CPR is conducted as long as deemed appropriate by the emergency care team, and could be 60-90 minutes in some cases, he says. "After there was no return of pulse for that entire time, and further medical treatment was determined to be futile, a potential donor would be pronounced dead by the emergency medical team," Callaway says. "A minimum of an additional two minutes of no-CPR time is allowed to pass after death is pronounced to be certain there is no occult cardiac activity, before we would make any preparations for donation."

In point of fact, he says, logistics create a natural delay of 10-15 minutes after death is pronounced. "All together, this sequence of events means that one, aggressive attempts to restore pulses with CPR were made prior to initiating the Condition T [to call a transplant team into the ED], and two, death is declared many minutes — even 60-90 minutes — after the potential donor's heart stopped."

Sources

For more information on organ donation in the ED, contact:

• Clifton Callaway, MD, PhD, Associate Professor of Emergency Medicine, University of Pittsburgh School of Medicine, Vice Chair of Emergency Medicine, University of Pittsburgh Medical Center, Pittsburgh. E-mail: callawaycw@upmc.edu.

• Leslie M. Whetstine, PhD, MA, Assistant Professor of Philosophy, Walsh University, North Canton, OH. Phone: (330) 499-7090.

So far, organs are not suitable

Organ donations in the ED present significant logistical challenges, as can be seen in a pilot program being carried out at University of Pittsburgh Medical Center (UPMC) Presbyterian Hospital and Allegheny General Hospital, both in Pittsburgh.

"We have had a number of donors — fewer than 10," says Clifton Callaway, MD, PhD, associate professor of emergency medicine, University of Pittsburgh School of Medicine, vice chair of emergency medicine at UPMC, and leader of the project. "Unfortunately, when we have executed the process, it has not resulted in organs that were suitable for transplant. "

Warm ischemia time under 30 minutes

Callaway says he attributes that lack of suitability to the total amount of warm ischemic time that had passed. "The total time duration to get the body cool and the organs out has been too long," says Callaway. "Ideally you want to have warm ischemia time of less than 30 minutes, but if you include CPR, we have had times of longer than an hour."

Achieving this goal "is logistically difficult," he says. "We've been able to have cold fluids started within 40 minutes or so." To improve those times, he says, the team has been seeking to streamline steps in the process, improve page operator response, and the speed with which the ED calls the local organ procurement organization.

"It's probably very analogous to reducing door-to-balloon time," says Callaway.


Clinical Tip

Infusion techniques can aid other EDs

The cold infusion techniques being used in a pilot program on ED organ donations represent a skill set that could be expanded into emergency procedures, says Clifton Callaway, MD, PhD, associate professor of emergency medicine, University of Pittsburgh School of Medicine, vice chair of emergency medicine at University of Pittsburgh Medical Center (UPMC) Presbyterian Hospital, and the project leader.

"In certain procedures you have cardiothoracic surgeons placing patients on ECMO [extracorporeal membrane oxygenation] rescue for severe cardiogenic shock," he says. "Having worked through such procedures with these other departments and now having placed these types of cannulae myself [for cold infusion], we should consider it an area and type of heroic procedure well within our scope of practice. Perhaps certain centers should explore it."